BEUDAMED
    FDA Enforcement Class II Terminated

    ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.

    Recall: Z-1752-2013 · Reported July 24, 2013

    Enforcement

    Recall Number
    Z-1752-2013
    Event ID
    65215
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxa Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 24, 2013
    Initiation Date
    June 4, 2013
    Classification Date
    July 18, 2013
    Termination Date
    October 16, 2015
    Address
    9540 Maroon Cir Unit 400, N/A, Englewood, CO, 80112-5731, United States

    Description

    ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.

    Reason

    Baxter Healthcare is recalling certain ExactaMix automated compounding devices due to the complementary metal oxide semi-conductor battery failure resulting in resetting the internal clock of the device to midnight December 31, 2010.

    Code Info

    ExactaMix 1200 serial numbers 45004-45481 (sequentially), and ExactaMix 2400 serial numbers 40005-40335.

    Distribution

    Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada, Latin America, Europe/Middle East/Africa, and Taiwan.

    Quantity

    753 units